Intrauterine contraceptive device

ABSTRACT

An intrauterine contraceptive device made from plastic and having a central core defining an intrauterine device nose, tail, and a pair of lateral side portions, and including retrograde spurs each having a bulbous contour, the spurs being arranged along the core side portions and of varying length so as to define a generally inverted pear shaped intrauterine device. Thin webs may be formed between adjacent spurs to increase the area of the invention, and multiple rows of spurs may be formed on each core side for better retention of the intrauterine device in the uterine cavity. A talisman and withdrawal cord may be attached to either end of the core.

United States Patent [1 1 Lerner Aug. 7, 1973 Assignee: A. H. Robins Company,

Incorporated, Richmond, Va.

Filed: June 23, 1971 Appl. No.: 155,768

References Cited UNITED STATES PATENTS 11/1952 Hyland 206/46 5/1918 Campbell 43/4226 11/1955 Accetta 43/4224 OTHER PUBLICATIONS Dalkron Shield publication of A. H. Robins Co. Nov.,

Primary Examiner-Richard A. Gaudet Assistant Examiner-G. F. Dunne Attorney-William A. Strauch, Philip E. Kurz et al.

[57] ABSTRACT An intrauterine contraceptive device made from plastic and having a central core defining an intrauterine device nose, tail, and a pair of lateral side portions, and including retrograde spurs each having a bulbous contour, the spurs being arranged along the core side portions and of varying length so as to define a generally inverted pear shaped intrauterine device. Thin webs may be formed between adjacent spurs to increase the area of the invention, and multiple rows of spurs may be formed on each core side for better retention of the intrauterine device in the uterine cavity. A talisman and withdrawal cord may be attached to either end of the core.

38 Claims, 5 Drawing Figures PATENTEU 3. 750.662

INVENTOR IRWIN S- LERNER ATTORN 1 INTRAUTERINE CONTRACEPTIVE DEVICE CROSS REFERENCE TO RELATED APPLICATIONS This invention relates to improvements in the intrauterine device disclosed and claimed in my prior copending application Ser. No. 775,729, filed Nov. 14, 1968, for INTRAUTERINE CONTRACEPTIVE DE- VICE, now US. Pat. No. 3,633,574, issued Jan. 11, 1972.

BACKGROUND OF THE INVENTION 1. Field Of The Invention The invention relates to the field of intrauterine contraceptive devices or IUDs, as they are now known, and more particularly to an improved IUD having a configuration to permit a maximum number of retrograde spurs extending therefrom whereby retention of the IUD within the uterine cavity is more positively assured.

2. Description Of The Prior Art As set forth in the aforementioned prior co-pending application, lUDs have had increased attention toward improving their characteristics in recent years because the population rate is becoming critical in many parts of the world. The IUD of the aforementioned application introduced a new concept in effective intrauterine contraception by providing a device engineered to accommodate physiological variations in the normal uterine cavity. That IUD is made of materials of exceptional resilience and has a light, flexible design so that expulsive contractions directed toward the broad upper nose portion of the IUD results in flaring and flexion at the apex or tail, increasing resistance to expulsion.

Broadly stated, the IUD disclosed and claimed in the aforementioned application comprises a ring having a membrane formed thereacross and retrograde spurs therearound to maximize endometrial surface contact, guard against intestinal strangulation in the event of uterine cavity perforation, minimize the possibility of expulsion, and render the device well tolerable by nulliparous as well as multiparous patients.

Although expulsion and pregnancy rates resulting from use of the aforedescribed IUD are entirely within presently acceptable parameters, continued development is underway to obtain a 100 percent effective IUD. It is this end to which the present invention is directed.

SUMMARY OF THE INVENTION It is a principal object of this invention to provide an increased area IUD in the form of a relatively narrow core section having a plurality of tissue engaging spurs along lateral sides thereof, the particular shape of the core permitting an increased number of spurs to be formed along the lateral sides, thereby enhancing the retention characteristics of the IUD.

It is another object of the invention to provide an IUD as described having a nose profile and spurs which may project relatively away from the core to a substantially retrograde inclination configuration for easing introduction into the uterus while imparting optimum retention characteristics.

Another object of the invention is to provide an IUD as described which includes relatively thin webs formed between adjacent spurs to even further increase the effective surface area of the IUD.

Yet another object of the invention is to provide an IUD as described having multiple rows of tissue engaging spurs to further enhance the retentive characteristics of the IUD.

Still another object of the invention is to provide an IUD of the type described wherein a talisman and withdrawal string may be attached at either end of the IUD.

Further novel features and other objects of this invention will become apparent from the following detailed description, discussion and the appended claims taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS Various structural embodiments of this invention are disclosed in the accompanying drawings, in which:

FIG. 1 is a plan view of one embodiment of the invention;

FIG. 2 is a sectional view taken along lines 22 of FIG. 1;

FIG. 3 is a view similar to FIG. 2, illustrating another embodiment of the invention;

FIG. 4 is another sectional view taken along lines 4-4 of FIG. 1, and drawn to an enlarged scale; and

FIG. 5 is a partial plan view of the invention as shown in FIG. 1, illustrating various other embodiments.

DESCRIPTION OF THE PREFERRED EMBODIMENTS The IUD of the present invention is somewhat caterpillar shaped as an inspection of FIG. 1 reveals, in that it comprises a relatively elongate central core 10 which defines a cervical entry end or nose 12, a trailing end or tail l4, and a pair of lateral sides l6, 16. Unlike the IUD of the prior corresponding application Ser. No. 775,729 wherein a membrane is formed across the central portion of a ring having external spurs arranged therealong, core 10 presents the inverse of the proposition by means of a relatively narrowly dimensioned core structure with appendages projecting therefrom to provide increased surface area.

The body of the present invention is filled and completed by the formation of a plurality of laterally extending tissue engaging spurs l8. Spurs 18 are arranged and configured so that nose spurs are substantially longer than rear spurs on core 10 and the intermediate spurs have lengths progressively decreasing from front to rear so that the entire IUD somewhat bears the appearance of an inverted pear. Such a shape is most closely akin to that of the normal uterus.

Each spur 18 is of increasingly tapered configuration outwardly towards its terminal free end where it is spherically rounded off as shown in cross-section in FIG. 4.'This configuration increases the surface area of each spur 18 substantially, thereby providing greater area for tissue contact and consequent partial tissue enfoldment of uterine cavity tissue about the IUD within the uterine cavity, but without expulsion of the IUD. At the same time, the smooth rounded surfaces on each spur l8 minimize the chances for injury to the cervical canal during insertion and to the uterine cavity after placement and positioning therein.

Still greater surface area for the IUD may be provided by a plurality of relatively thin scalloped webs 20 formed between adjacent spurs 18. Each web may extend beyond the space encompassed between adjacent spurs as at 22 (FIG. 5) and/or be separated from each adjacent spur and attached only to the fillet therebetween as at 24 (FIG. 5). In another embodiment, the IUD may be formed with no webs at all, as shown in the lower left portion of FIG. 5.

In the embodiment illustrated by sectional FIG. 2,

' two planar rows of spurs'l8 are shown extending out- A talisman and withdrawal cord 28 is attached to tail 14 of the IUD for withdrawal of the IUD from the titerine cavity after use. Cord 28 may have a knot therein (not shown) which visually indicates and confirms proper insertion depth once the IUD is placed and positioned within the uterine cavity. For greater ease of withdrawal, cord 28 may alternatively be attached to nose 12 of the IUD so that upon withdrawal-from the uterine cavity, the IUD willinvert within the uterus, thereby allowing spurs 18 to be in a position tapered away from the direction of withdrawal to minimize the possibility of tissue damage during the withdrawal process.

It will be noted from the Figures that each spur 18 has a retrograde inclination from nose [2 to tail 14. The angle of inclination 6 (FlG..l) for each spur l8 may vary considerably, from 0 to 75 with respect to a line normalthrough the elongate major axis of core 10. Stated alternatively, the angle of retrogradeinclination may vary from 90to 15 with respect to the long axis of core 10. Preferably the spurs adjacent nose 12 will have a lesser degree of retrograde inclination than those near tail 14. Such a slanted configuration assures that most of the sprus 18 will contact some portion of the tissues of the uterine cavity once the IUD is positioned therein, and the retrograde inclination of each spur 18 aids in preventing expulsion of the IUD by normal muscle contractions of the uterus. Additionally, the retrograde inclination of spurs l8 facilitates insertion ease, in that the spurs are inclined away from the direction of insertion. 1

The combined relative length and outer end thickness of each spur 18 when compared with the somewhat more narrow junction of each spur 18 to lateral side walls 16 of core permits each spur 18 to flex somewhat, particularly within a plane conincident with the major plane of the IUD (FIG. I) so that each s'pur 18 may accommodate itself to the particular internal tissue configuration of the uterine cavity into which the IUD is inserted.

The material of the IUD is preferably an easily molded, plastic, which is light and flexible. Among others, such material could be ULTRATHENE," polyethylene, polypropylene, ethylene, or propylene.

The invention may be embodied in other specific forms without departing from the scope, spirit or essential characteristics thereof. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive, the scope and spirit of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are, therefore, intended to be embraced therein.

What is claimed and desired to be secured by Letters Patent is:

1. An intrauterine contraceptive device made from material enabling flexing to conform to the uterine cavity comprising: an elongate, stem-like, relatively rigid, central core body of substantial thickness forming the structural main member of said device and having a nose, tail and lateral side portions defined therealong, and encompassing an area substantially less than that of an average normal condition uterine cavity, and a plurality of closely spaced elongate spurs, with smoothly contoured terminal portions, extending outwardly from each of said side portions.

2. The device of claim 1 wherein all of said spurs are disposed in a common plane.

3. The device of claim 2 wherein at least some of said spurs have an inclination toward the tail portion.

4. The device of claim 2 wherein all of said spurs have an inclination toward the tail portion.

5. The device of claim 2 wherein the spurs closest to the nose portion are longer than the spurs closest to the tail portion.

6. The device of claim 2 wherein pull line means are secured to said intrauterine device to enable removal after insertion.

7. The device of claim 2 whereinthin webs integral with said lateral sides are disposed on each side between at least two adjacent ones of said elongate spurs.

8. The device of claim 7 wherein said thin webs are disposed between all adjacent pairs of elongate spurs on each of said lateral sides.

9. The device of claim 7 wherein each of said thin webs is attached only to a lateral side and is disposed loose between said adjacent elongate spurs.

10. The device of claim 7 wherein each of said thin webs is attached to a lateral side and is also secured to said adjacent elongate spurs.

11. The device of claim 7 wherein each of said thin webs is shorter than the length of said adjacent spurs.

12. The device of claim 11 wherein said shorter thin webs are disposed between all adjacent pairs of elongate spurs on each of said lateral sides.

13. The device of claim 11 wherein each of said thin webs between adjacent spurs is attached only to a lateral side and is disposed loose between said adjacent elongate spurs.

14. The device of claim 11 wherein each of said thin webs between adjacent spurs is attached to a lateral side and is also secured to said adjacent elongate spurs.

' 15. The device of claim 7 wherein each of said thin webs protrudes outwardly beyond the terminal ends of said adjacent spurs.

16. The device of claim 1, wherein at least the terminal portions of said spurs are bulbous.

17. The device of claim 1, wherein a plurality of rows of elongate spurs are disposed on each of said lateral sides.

18. The device of claim 17, wherein the elongate spurs in all of said rows on each of said lateral sides are side by side in a direction normal to the general planar shape of the device.

19. The device of claim 17, wherein at least a portion of the elongate spurs have an inclination toward the tail portion.

20. The device of claim 17, wherein all of said elongate spurs have an inclination toward the tail portion.

21. The device of claim 17, wherein the spurs closest to the nose portion are longer than the spurs closest to the tail portion.

22. The device of claim 17, wherein pull line means are secured to said intrauterine device to enable removal after insertion.

23. The device of claim 17, wherein thin webs integral with said lateral sides are disposed on each side between at least two adjacent ones of said elongate spurs.

24. The device of claim 23, wherein thin webs integral with said lateral sides are disposed on each side between at least two adjacent pairs of elongate spurs on each of said lateral sides in a plane normal to the general planar shapeof the device.

25. The device of claim 24, wherein additional thin webs integral with said lateral sides are disposed on each side between said first recited thin webs.

26. The device of claim 25, wherein each of said additional thin webs is shorter than the length of said adjacent spurs.

27. The device of claim 26, wherein each of said additional thin webs is attached only to a lateral side and is disposed loose between said first recited thin webs.

28. The device of claim 26, wherein each of said additional thin webs is attached to a lateral side and is also secured to said first recited thin webs.

29. The device of claim 25, wherein each of said additional thin webs protrudes outwardly beyond the terminal ends of said adjacent spurs.

30. The device of claim 23, wherein thin webs integral with said lateral sides are disposed between all adjacent pairs of elongate spurs on each of said lateral sides in a plane normal to the general planar shape of the device.

31. The device of claim 30, wherein additional thin webs integral with said lateral sides are disposed on each side between said first recited thin webs.

32. The device of claim 31, wherein each of said additional thin webs is shorter than the length of said adjacent spurs.

33. The device of claim 32, wherein each of said additional thin webs is attached only to a lateral side and is disposed loose between said first recited thin webs.

34. The device of claim 32, wherein each of said additional thin webs is attached to a lateral side and is also secured to adjacent said first recited thin webs.

35. The device of claim 31, wherein each of said additional thin webs protrudes outwardly beyond the terminal ends of said adjacent spurs.

36. The device of claim 17, wherein at least the terminal portions of said spurs are bulbous.

37. The device of claim 1, wherein at least six spurs extend from each of said side portions.

38. A device as defined in claim 1 made from a plastic material comprising an ethylene vinyl copolymer. 

1. An intrauterine contraceptive device made from material enabling flexing to conform to the uterine cavity comprising: an elongate, stem-like, relatively rigid, central core body of substantial thickness forming the structural main member of said device and having a nose, tail and lateral side portions defined therealong, and encompassing an area substantially less than that of an average normal condition uterine cavity, and a plurality of closely spaced elongate spurs, with smoothly contoured terminal portions, extending outwardly from each of said side portions.
 2. The device of claim 1 wherein all of said spurs are disposed in a common plane.
 3. The device of claim 2 wherein at least some of said spurs have an inclination toward the tail portion.
 4. The device of claim 2 wherein all of said spurs have an inclination toward the tail portion.
 5. The device of claim 2 wherein the spurs closest to the nose portion are longer than the spurs closest to the tail portion.
 6. The device of claim 2 wherein pull line means are secured to said intrauterine device to enable removal after insertion.
 7. The device of claim 2 wherein thin webs integral with said lateral sides are disposed on each side between at least two adjacent ones of said elongate spurs.
 8. The device of claim 7 wherein said thin webs are disposed between all adjacent pairs of elongate spurs on each of said lateral sides.
 9. The device of claim 7 wherein each of said thin webs is attached only to a lateral side and is disposed loose between said adjacent elongate spurs.
 10. The device of claim 7 wherein each of said thin webs is attached to a lateral side and is also secured to said adjacent elongate spurs.
 11. The device of claim 7 wherein each of said thin webs is shorter than the length of said adjacent spurs.
 12. The device of claim 11 wherein said shorter thin webs are disposed between all adjacent pairs of elongate spurs on each of said lateral sides.
 13. The device of claim 11 wherein each of said thin webs between adjacent spurs is attached only to a lateral side and is disposed loose between said adjacent elongate spurs.
 14. The device of claim 11 wherein each of said thin webs between adjacent spurs is attached to a lateral side and is also secured to said adjacent elongate spurs.
 15. The device of claim 7 wherein each of said thin webs protrudes outwardly beyond the terminal ends of said adjacent spurs.
 16. The device of claim 1, wherein at least the terminal portions of said spurs are bulbous.
 17. The device of claim 1, wherein a plurality of rows of elongate spurs are disposed on each of said lateral sides.
 18. The device of claim 17, wherein the elongate spurs in all of said rows on each of said lateral sides are side by side in a direction normal to the general planar shape of the device.
 19. The device of claim 17, wherein at least a portion of the elongate spurs have an inclination toward the tail portion.
 20. The device of claim 17, wherein all of said elongate spurs have an inclination toward the tail portion.
 21. The device of claim 17, wherein the spurs closest to the nose portion are longer than the spurs closest to the tail portion.
 22. The device of claim 17, wherein pull line means are secured to said intrauterine device to enable removal after insertion.
 23. The device of claim 17, wherein thin webs integral with said lateral sides are disposed on each side between at least two adjacent ones of said elongate spurs.
 24. The device of claim 23, wherein thin webs integral with said lateral sides are disposed on each side between at least two adjacent pairs of elongate spurs on each of said lateral sides in a plane normal to the general planar shape of the device.
 25. The device of claim 24, wherein additional thin webs integral with said lateral sides are disposed on each side between said first recited thin webs.
 26. The device of claim 25, wherein each of said additional thin webs is shorter than the length of said adjacent spurs.
 27. The device of claim 26, wherein each of said additional thin webs is attached only to a lateral side and is disposed loose between said first recited thin webs.
 28. The device of claim 26, wherein each of said additional thin webs is attached to a lateral side and is also secured to said first recited thin webs.
 29. The device of claim 25, wherein each of said additional thin webs protrudes outwardly beyond the terminal ends of said adjacent spurs.
 30. The device of claim 23, wherein thin webs integral with said lateral sides are disposed between all adjacent pairs of elongate spurs on each of said lateral sides in a plane normal to the general planar shape of the device.
 31. The device of claim 30, wherein additional thin webs integRal with said lateral sides are disposed on each side between said first recited thin webs.
 32. The device of claim 31, wherein each of said additional thin webs is shorter than the length of said adjacent spurs.
 33. The device of claim 32, wherein each of said additional thin webs is attached only to a lateral side and is disposed loose between said first recited thin webs.
 34. The device of claim 32, wherein each of said additional thin webs is attached to a lateral side and is also secured to adjacent said first recited thin webs.
 35. The device of claim 31, wherein each of said additional thin webs protrudes outwardly beyond the terminal ends of said adjacent spurs.
 36. The device of claim 17, wherein at least the terminal portions of said spurs are bulbous.
 37. The device of claim 1, wherein at least six spurs extend from each of said side portions.
 38. A device as defined in claim 1 made from a plastic material comprising an ethylene vinyl copolymer. 